Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K903736 |
Device Name |
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL |
Applicant |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
BILL CORRIGAN |
Correspondent |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
BILL CORRIGAN |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 08/16/1990 |
Decision Date | 10/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|